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SafetyPIPAC-SecureNCT04014426

Evaluation of Healthcare Workers Safety During Pressurized Intraperitoneal Aerosol Chemotherapy

A study testing Blood sample and Urinary sample in people with Safety and Healthy Volunteers, run by Institut du Cancer de Montpellier - Val d'Aurelle at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Pressurized intraperitoneal aerosol chemotherapy (PIPAC) is a new treatment that applies chemotherapeutic drugs into the peritoneal cavity as an aerosol. It is used to treat patient with Peritoneal Carcinomatosis (PC). During this procedure, healthcare workers may be under risks of exposure to cytotoxic treatments. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Safety, Healthy Volunteers
What is being tested?
Blood sample and Urinary sample
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteFrance
Study dates
2 Jan 2018to 4 Jul 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Male or female subjects ≥ 18 and ≤ 70 years old
  • Exposed subjects: The healthcarers involved in two different PIPAC using oxaliplatin (Surgeon, Anesthesiste, Block nurse …)
  • Non-exposed subjects: Healthy volunteers not exposed to oxaliplatin or other platin based chemotherapy (administrative function).
  • Must be affiliated to a social security system
  • Informed consent agreement and signature

Who cannot join

  • Legal incapacity or physical, psychological or mental status interfering with the subject's ability to sign the inform consent or to terminate the study

Trial locations and contacts

1 site in 1 country.

France1 site

  • ICM - Val d'Aurelle

    Montpellier, 34298

Other trials in France

About this study

Official title: Evaluation of Oxaliplatin Exposure and Security of Healthcare Workers During Pressurized Intraperitoneal Aerosol Chemotherapy

Pressurized intraperitoneal aerosol chemotherapy (PIPAC) is a new treatment that applies chemotherapeutic drugs into the peritoneal cavity as an aerosol. It is used to treat patient with Peritoneal Carcinomatosis (PC). During this procedure, healthcare workers may be under risks of exposure to cytotoxic treatments.

The purpose of this study is to evaluate the safety of the heathcare workers and the risk of operation room Oxaliplatin's contamination during a PIPAC.

Read the detailed description

Peritoneal carcinomatosis (PC), which was long considered as a terminal stage, is now potentially curable. Nevertheless, in most cases, the surgical treatment of PC is limited by the disease extent which is commonly measured with the Peritoneal Carcinomatosis Index (PCI). For the patients that are not considered good candidates for resection, there are very few alternatives. Systemic chemotherapy may have limited or no effect therefore an alternative solution is needed for these patients.

Pressurized intraperitoneal aerosol chemotherapy (PIPAC) is a new treatment that applies chemotherapeutic drugs into the peritoneal cavity as an aerosol under pressure through minimal laparoscopic surgery.

Nevertheless, as it is the case for most technologies, security is not always completely tested. The innovative team started by establishing a set of security rules that concern the operating room ventilation, distance monitoring of the patient during nebulization, evacuation of the aerosols in a closed system. In a work dedicated to occupational hazards, the authors followed the following steps: identification of hazardous substances and dose; identification of possible exposure ways; simulation of the PIPAC procedure with nontoxic aerosols and smoke; redaction of standard operating procedures (SOP); second simulation according to the SOP; informing and training the health care workers; and performance of the first two PIPAC procedures with chemotherapeutic substances and workplace measurements under real conditions. At the end of the study, there were no traces of doxorubicin or cisplatin (the two drugs used in the two consecutive test procedures) in the operating room air, neither to the position of the anesthesiologist, nor of the surgeon.

This study does not concern PIPAC with oxaliplatin, nor does it research the presence of the drugs in the health caregivers.

Therefore we considered mandatory to further investigate occupational hazards in the specific case of oxaliplatin by focusing more on the healthcare workers and partially applying the same protocols as in the case of Heated intraperitoneal chemotherapy (HIPEC).

Being tested
Blood sample, Urinary sample
Keywords
Peritoneal Carcinomatosis, Healthcare Workers, Security, Pressurized Intraperitoneal Aerosol Chemotherapy, Aerosols/administration & dosage, Oxaliplatin
Medical subject headings
Peritoneal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Blood sampleOther

    Exposed group:

    • 15 to 30 minutes before the start of the procedure: 1 EDTA tube of 6 ml for blood (T0)
    • 2hours after the end of the procedure: 1 EDTA tube of 6 ml (T1)

    Non-exposed group:

    • During the morning (8 to 10 a.m): 1 EDTA tube of 6 ml (T0)

  • Urinary sampleOther

    Exposed group:

    • 15 to 30 min before the PIPAC procedure (T0)
    • 2hours after the end of the procedure (T1)
    • The next morning after the procedure (T2)

    Non-exposed group:

    • During the morning (8 to 10 a.m) (T0)
Study groups in NCT04014426
Study groupRoleWhat they receive
ExposedOtherHealthcare workers participating at two PIPAC
Receives: Other: Blood sample; Other: Urinary sample
Non-exposedOtherHealthy volunteers unexposed to chemotherapy
Receives: Other: Blood sample; Other: Urinary sample

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Blood levels of oxaliplatin - Exposed group

    Blood levels of oxaliplatin in healthcare workers in two PIPAC

    Measured: Change from before PIPAC and 2hours after PIPAC

  2. Blood levels of oxaliplatin - Non-exposed group

    Blood levels of oxaliplatin in heathy subject non-exposed to chemotherapy

    Measured: At baseline

  3. Urinary levels of oxaliplatin - Exposed group

    Urinary levels of oxaliplatin in healthcare workers in two PIPAC

    Measured: Change from before PIPAC, 2hours after PIPAC and the next day after PIPAC

  4. Urinary levels of oxaliplatin - Non-exposed group

    Urinary levels of oxaliplatin in heathy subject non-exposed to chemotherapy

    Measured: At baseline

Secondary outcomes (1)

  1. Oxaliplatin contamination of the operating room

    Oxaliplatin dosed on standardized gazes used to clear four different spots in the operating room: the ceiling lamp, the electroagulation device, the laparoscopy tower and the anesthesia monitoring screen

    Measured: Before PIPAC and 10min after PIPAC

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jul 2019
  2. Study start2 Jan 2018
  3. Primary completion4 Jul 2018
  4. Study completion4 Jul 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Exposed/ Non-exposed
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04014426
Sponsor's protocol ID
ICM-URC 2017/36
Acronym
PIPAC-Secure
Status last verified
Jun 2019
First submitted
1 Jul 2019
Last updated
10 Jul 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Tempfer CB, Celik I, Solass W, Buerkle B, Pabst UG, Zieren J, Strumberg D, Reymond MA. Activity of Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) with cisplatin and doxorubicin in women with recurrent, platinum-resistant ovarian cancer: preliminary clinical experience. Gynecol Oncol. 2014 Feb;132(2):307-11. doi: 10.1016/j.ygyno.2013.11.022. Epub 2013 Nov 23.

    PubMed 24275155

  • Markman M. Intraperitoneal antineoplastic drug delivery: rationale and results. Lancet Oncol. 2003 May;4(5):277-83. doi: 10.1016/s1470-2045(03)01074-x.

    PubMed 12732164

  • Solass W, Giger-Pabst U, Zieren J, Reymond MA. Pressurized intraperitoneal aerosol chemotherapy (PIPAC): occupational health and safety aspects. Ann Surg Oncol. 2013 Oct;20(11):3504-11. doi: 10.1245/s10434-013-3039-x. Epub 2013 Jun 14.

    PubMed 23765417

  • Larroque M, Arnaudguilhem C, Bouyssiere B, Quenet F, Bouazza N, Jarlier M, Boulabas S, Mounicou S, Sgarbura O. Evaluation of the environmental contamination and exposure risk in medical/non-medical staff after oxaliplatin-based pressurized intraperitoneal aerosol chemotherapy. Toxicol Appl Pharmacol. 2021 Oct 15;429:115694. doi: 10.1016/j.taap.2021.115694. Epub 2021 Aug 21.

    PubMed 34428445

Questions about this trial

What is this clinical trial studying?

A study testing Blood sample and Urinary sample in people with Safety and Healthy Volunteers, run by Institut du Cancer de Montpellier - Val d'Aurelle at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Blood levels of oxaliplatin - Exposed group (time frame: Change from before PIPAC and 2hours after PIPAC). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04014426, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2019.

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